Study of the Bioequivalence of Gliclazide in Chinese Healthy Volunteers

Objective To study the relative bioavailability and bioequivalence of gliclazide tablets in healthy volunteers. Methods A single oral dose(80 mg of tested and reference formulation) was given to 20 healthy volunteers in a randomized crossover study.The concentrations of gliclazide in plasma were determined by HPLC.The pharmacokinetics parameters were calculated and the bioavailability and bioequivalence of two formulations were evaluated by DAS program. Results After a single dose,the pharmacokinetics parameters for gliclazide were as follows: C_(max) were(5.34±0.66) mg·L~(-1)and(5.12±0.39) mg·L~(-1);t_(max) were(4.30±0.92) h and(4.15±0.67) h;AUC_((0-60))were(92.67±12.12) mg·h·L~(-1) and(89.82±13.33) mg·h·L~(-1);AUC_((0-inf)) were(96.36±12.87) mg·h·L~(-1) and(93.37±13.83) mg·h·L~(-1) for T and R,respectively.The 90% confidential interval of C_(max),AUC_((0-60) )and AUC_((0-inf)) of tested formulation were 100.52%～107.56%,99.16%～107.97% and 99.16%～107.97% respectively. Conclusion The relative bioavailability is(104.5±15.5)%.The results of the statistic analysis show that the two formulations exhibit bioequivalence.